Laparoscopic CholecystectomyENVNCT04561583
Effectiveness and Safety of LED Light Source System for Endoscope
A study testing LED light source system for endoscope and Pinpoint Endoscopic Fluorescence Imaging System in people with Laparoscopic Cholecystectomy, run by Stryker Orthopaedics at 4 sites in China.
Trial summary
This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- LED light source system for endoscope and Pinpoint Endoscopic Fluorescence Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria:
- Subjects who should receive laparoscopic cholecystectomy on a selected day Symptoms of such subjects include gallstone, cholecystitis, or gallbladder polyp≥0.8 cm
- Aged between 18 and 75
- All subjects voluntarily participate in the clinical trial and are asked to sign the informed consent form
- Exclusion Criteria:
- Subjects suffering acute cholecystitis and cholangitis
- Subjects requiring laparotomy
- Women during pregnancy or lactation
- Subjects expected to give birth to a child within 3 months after the trial
- Subjects suffering liver cirrhosis
- Subjects allergic to ICG or iodine
- Subjects with cardiopulmonary insufficiency and those intolerant of surgery
- Subjects with abnormal renal and liver function: ①Aspartate aminotransferase AST or alanine aminotransferase ALT exceeding 3 times of the upper limit of the normal range; ② Serum creatinine > 2.0 mg/dL or ≥ 176.8 μmol/L
- Subjects with history of malignant cancer or subjects with malignant cancer
- Subjects currently engaged in other clinical trials
- Subjects deemed by the investigators as unsuitable for the trial
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, 100000
Xuanwu Hospital, Capital Medical University
Beijing, 100000
The First Affiliated Hospital of Jilin University
Changchun, Jilin, 130000
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: A Prospective, Multi-center, Single-blind, Parallel, Randomized Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the LED Light Source System for Endoscope During Ureter Transillumination.
This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).
This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period.
Read the detailed description
The prospective, multi-center, single-blind, parallel, randomized controlled non-inferiority trial design is adopted to evaluate the safety and effectiveness of the real-time endoscopic near infrared fluorescence image provided by the LED light source system for endoscope by evaluating at least one main extrahepatic bile duct (common bile duct and ductuli hepaticus communis). The trial will be carried out in 5 centers, with the competitive grouping mode adopted. Totally 220 patients to receive laparoscopic cholecystectomy will be involved (110 patients for each of the control group and the test group). The subjects, after signing the informed consent form approved by the Ethics Committee, will be screened by the investigators. Qualified subjects who meet all the inclusion criteria and do not meet any of the exclusion criteria will be randomly divided into the control group or the test group. For the subjects in the control group, the Pinpoint Endoscopic Fluorescence Imaging System commercially available will be used for operation. For subjects of the test group, the LED light source system for endoscope will be used for operation. On the operation date, investigators will evaluate the display performance of the device by judging whether at least one main extrahepatic bile duct (common bile duct and ductuli hepaticus communis) is displayed. During the follow-up period, the investigators will evaluate the safety of the device based on the results of vital signs, physical examination, blood routine examination, routine urine examination, blood biochemistry and 12-lead ECG.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- LED light source system for endoscope, Pinpoint Endoscopic Fluorescence Imaging System
- Keywords
- gallstone, cholecystitis, gallbladder polyp
- Medical subject headings
- Gallstones, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED light source system for endoscopeDevice
This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).
This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period.
Pinpoint Endoscopic Fluorescence Imaging SystemDevice
This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).
This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| LED light source system for endoscope | Other | This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).Test grop use LED light source system for endoscope Receives: Device: LED light source system for endoscope |
| Pinpoint Endoscopic Fluorescence Imaging System | Other | This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).control group use Pinpoint Endoscopic Fluorescence Imaging System (Model: PC9000) Receives: Device: Pinpoint Endoscopic Fluorescence Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization rate of extrahepatic bile duct.
Note: The visualization rate of extrahepatic bile duct refers to the visualization rate of at least one extrahepatic bile duct (the ductuli hepaticus communis and common bile duct) after dissection of the calot's triangle (the images are taken respectively before unfolding the anatomical structure, during dissection and after complete unfolding of the triangular structure).
Measured: During the operation
Secondary outcomes (4)
Time of operation
Time of operation
Measured: During the operation
Intraoperative blood loss
Intraoperative blood loss
Measured: During the operation
the occurrence rate of complications
bile duct injury, bile leakage, hemorrhage, secondary abdominal infection
Measured: Postoperative follow-up period was up to 7 days
Device failure rate
Device failure rate
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: The study was registered but never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects). This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongtao Zhang, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561583
- Sponsor's protocol ID
- Stryker02
- Acronym
- ENV
- Status last verified
- Apr 2021
- First submitted
- 1 Sep 2020
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Study Protocol will be shared
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-blind, Parallel, Randomized Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the LED Light Source System for Endoscope During Ureter Transillumination.
- ClinicalTrials.gov ID
- NCT04561583
- Acronym / sponsor ID
- ENV / Stryker02
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- gallstone, cholecystitis, gallbladder polyp
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was registered but never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).
This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period.
Detailed description
The prospective, multi-center, single-blind, parallel, randomized controlled non-inferiority trial design is adopted to evaluate the safety and effectiveness of the real-time endoscopic near infrared fluorescence image provided by the LED light source system for endoscope by evaluating at least one main extrahepatic bile duct (common bile duct and ductuli hepaticus communis). The trial will be carried out in 5 centers, with the competitive grouping mode adopted. Totally 220 patients to receive laparoscopic cholecystectomy will be involved (110 patients for each of the control group and the test group). The subjects, after signing the informed consent form approved by the Ethics Committee, will be screened by the investigators. Qualified subjects who meet all the inclusion criteria and do not meet any of the exclusion criteria will be randomly divided into the control group or the test group. For the subjects in the control group, the Pinpoint Endoscopic Fluorescence Imaging System commercially available will be used for operation. For subjects of the test group, the LED light source system for endoscope will be used for operation. On the operation date, investigators will evaluate the display performance of the device by judging whether at least one main extrahepatic bile duct (common bile duct and ductuli hepaticus communis) is displayed. During the follow-up period, the investigators will evaluate the safety of the device based on the results of vital signs, physical examination, blood routine examination, routine urine examination, blood biochemistry and 12-lead ECG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects). This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period.
| Arm | Type | Receives |
|---|---|---|
| LED light source system for endoscope | Other | Device: LED light source system for endoscopeThis trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).Test grop use LED light source system for endoscope |
| Pinpoint Endoscopic Fluorescence Imaging System | Other | Device: Pinpoint Endoscopic Fluorescence Imaging SystemThis trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).control group use Pinpoint Endoscopic Fluorescence Imaging System (Model: PC9000) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LED light source system for endoscopeThis trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects). This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period. | Device | LED light source system for endoscope |
| Pinpoint Endoscopic Fluorescence Imaging SystemThis trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects). This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period. | Device | Pinpoint Endoscopic Fluorescence Imaging System |
Primary outcome
Visualization rate of extrahepatic bile duct.
Time frame: During the operation
Note: The visualization rate of extrahepatic bile duct refers to the visualization rate of at least one extrahepatic bile duct (the ductuli hepaticus communis and common bile duct) after dissection of the calot's triangle (the images are taken respectively before unfolding the anatomical structure, during dissection and after complete unfolding of the triangular structure).
4 secondary outcomes
Time of operation
Time frame: During the operation
Intraoperative blood loss
Time frame: During the operation
the occurrence rate of complications
Time frame: Postoperative follow-up period was up to 7 days
Device failure rate
Time frame: During the operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: Yes. Study Protocol will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongtao Zhang principal investigator
Beijing Friendship Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED light source system for endoscope and Pinpoint Endoscopic Fluorescence Imaging System in people with Laparoscopic Cholecystectomy, run by Stryker Orthopaedics at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization rate of extrahepatic bile duct. (time frame: During the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.